Axis-Shield's Active-B12 test gets US approval

Dundee, Scotland-based in vitro diagnostics company Axis-Shield has received US Food and Drug Administration marketing approval for its Active-B12 test. This runs on health care major Abbott Laboratories' AxSYM automated immunoassay system, which is used in thousands of hospitals and clinical laboratories worldwide.

The test measures levels of holotranscobalamin, the active, biologically-available form of vitamin B12, deficiency of which may be implicated in neurodegenerative conditions such as Alzheimer's disease and is an increasing problem amongst elderly and vegetarian populations.

The Active-B12 test is a more effective measurement of early deficiency of this important vitamin than existing methods of detection, according to the firm, because only 20% of absorbed B12 is present in this active form, the conventional measurement of total B12 levels may mask deficiency and additionally there is a significant zone of indeterminacy where total B12 results require retesting. The use of the Active-B12 will allow improved detection of deficiency, significantly reducing the need for assay repetition, Axis-Shield noted.